Head of Manufacturing Science at Round Lake

Head of Manufacturing Sciences

Location:

Round Lake, Illinois (Onsite)

As a Head of Manufacturing Sciences, you will report directly to the Site Head and serve as a key member of the Round Lake Site Leadership Team. You will provide strategic and technical leadership for all Manufacturing Sciences activities supporting Round Lake operations, including technical oversight of drug product manufacturing processes, process validation, continued process verification, lifecycle management, process optimization, technical investigations, and manufacturing support for the Round Lake site.

The site is a specialized aseptic fill‑finish facility within Takeda’s Plasma‑Derived Therapies network, manufacturing Flexbumin® (Human Albumin) utilizing proprietary GALAXY sterile filling technology. You will partner closely with Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, Supply Chain, and global technical functions to ensure reliable supply, operational excellence, regulatory compliance, and continuous improvement. Building and developing a high‑performing team of scientists and engineers while driving innovation, technical rigor, and operational performance across the site will be a critical aspect of this leadership role.

• Technical Leadership: Serve as the site technical authority for Flexbumin manufacturing processes and aseptic fill‑finish operations; lead the Manufacturing Sciences organization responsible for process support, monitoring, capability improvement, and lifecycle management; provide technical oversight and approval of process validation strategies, continued process verification (CPV), process performance monitoring, technology transfers, process changes, and technical investigations.
• Manufacturing Support: Provide real‑time technical support for commercial manufacturing operations; lead complex troubleshooting activities and root‑cause investigations; drive rapid resolution of deviations, recurring process issues, and product quality concerns; partner with Operations and Quality to improve right‑first‑time performance and reduce process variability; support uninterrupted product supply through proactive risk identification and mitigation.
• Process Improvement & Innovation: Develop and execute site process improvement strategies; leverage Lean, Six Sigma, and data‑driven methodologies to improve process capability, yield, reliability, and productivity; identify opportunities for modernization, automation, digital analytics, and process innovation; support capital projects and process enhancement initiatives.
• Regulatory Compliance & Inspection Readiness: Ensure compliance with cGMP and global regulatory requirements; provide technical leadership during regulatory inspections and audits; maintain inspection‑ready documentation; support regulatory submissions and responses related to process changes and validation activities.
• Leadership & Talent Development: Lead, coach, and develop a team of Manufacturing Sciences managers, scientists, and engineers; build technical capabilities and succession pipelines; foster a culture of accountability, continuous improvement, collaboration, and scientific excellence; serve as a role model for Takeda’s values and leadership behaviors.
• Network & Global
  
  Collaboration:
  
  Partner with Manufacturing Sciences leaders across the Global Plasma Operating Unit; collaborate with global technical functions to align process strategies and share best practices; support strategic initiatives that improve network performance, product robustness, and patient supply.

• Bachelor’s degree in engineering, pharmaceutical sciences, chemistry, biochemistry, biotechnology, or a related scientific discipline.
• Advanced degree (MS, PhD, or equivalent) preferred.
• Minimum 15 years of experience in pharmaceutical, biotech, biologics, or plasma‑derived product manufacturing.
• Minimum 8 years of progressive leadership experience managing technical teams.
• Demonstrated experience supporting commercial manufacturing operations in regulated GMP environments.
• Strong experience in aseptic processing and fill‑finish manufacturing.
• Ex…